Flecainide Acetate

Orange BookUNIISPLATC C01BC04

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerHikma Pharmaceuticals USA Inc.

CountryUS (United States)

ATC codeC01BC04

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 3

ndc11
0054001020
100 BLISTER PACK in 1 CARTON (0054-0010-20) / 1 TABLET in 1 BLISTER PACK
ndc11
0054001021
60 TABLET in 1 BOTTLE (0054-0010-21)
ndc11
0054001025
100 TABLET in 1 BOTTLE (0054-0010-25)

Annotations

UNII (FDA Substance ID)

M8U465Q1WQ

FLECAINIDE ACETATE

RxCUI 42686

Orange Book

A076278

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "M8U465Q1WQ",
    "rxcui": "42686",
    "inchikey": "RKXNZRPQSOPPRN-UHFFFAOYSA-N",
    "display_name": "FLECAINIDE ACETATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "74c1eb2a-a37f-4f33-86bf-51e0d1d0c2bc": {
      "match": "brand_token",
      "title": "FLECAINIDE ACETATE TABLET [EPIC PHARMA, LLC]",
      "spl_version": "8",
      "published_date": "2026-06-01"
    }
  },
  "productid": "0054-0010_e34a6adf-8794-426e-9e43-11060803a90d",
  "productndc": "0054-0010",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "076278",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "50MG",
        "product_no": "001",
        "approval_date": "Jan 14, 2003"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "002",
        "approval_date": "Jan 14, 2003"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AB",
        "strength": "150MG",
        "product_no": "003",
        "approval_date": "Jan 14, 2003"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "FLECAINIDE ACETATE",
  "proprietary_name": "Flecainide Acetate",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA076278",
  "marketing_category": "ANDA",
  "nonproprietary_name": "flecainide acetate",
  "start_marketing_date": "20030114",
  "active_numerator_strength": "50"
}

Related drugs

Other records sharing ATC code C01BC04.

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